Medical knowledge in the areas of both diagnosis and treatment is now so advanced that good health care, in the aggregate, is as much a function of society's ability to pay as it is a function of the state of knowledge about proper health care. This fact has vastly increased the pessure on health care planners and administrators to seek greater cost effectiveness in health care delivery. One obvious technique has been to employ computerized data handling.
A variety of computerized data handling systems exist ranging from a computer assisted system for taking patient medical histories as disclosed in U.S. Pat. No. 4,130,881 to extremely sophisticated systems such as that recently instituted in a California hospital in which virtually all of the data handling functions within the hospital were computerized, 123 Cong. Rec. (June 10, 1977) (Remarks of Congressman Ottinger). A limited degree of success in reducing hospital costs has been achieved by the use of these systems. However, health care costs have continued to rise at a rate which far exceeds the rate of increase in the cost of living. Annual amounts spent for health care now account for about 10 percent of the Gross National Product and could easily exceed 229 billion dollars by 1981, double the amount spent in 1976. Prior attempts at computerization of data handling functions within the health care industry have generally centered around the use of electronic data handling as a mere substitution for normal recordation and transmission of information. While such attempts are certainly useful insofar as they go, they have failed to capitalize on the immense power of modern electronic data handling systems to sift, categorize and format information in a way which measurably improves the efficiency of individual medical practitioners.
One explanation for lack of success in health care cost containment despite wide spread use of computerized data handling is the fact that the amount of potentially relevant data has been expanding enormously. A careful medical practitioner thus requires vastly greater amounts of such information as laboratory test results, diagnostic information and pharmacological alternatives for treatment than was true only a decade ago when computers were first introduced. For example, in the last decade the number of available diagnostic laboratory tests has doubled and heretofore unknown diagnostic procedures are now commonly performed. The body of medical knowledge has undergone such an exponential increase that decisions regarding the best medical treatment can be reached only after careful consideration of a vast quantity of input. Generation of this input is extremely expensive and often turns out subsequently to have been unnecessary.
Further compounding this problem is the fact that health care planners and administrators are now calling upon the individual physician to be cost conscious regarding each of his diagnostic and treatment decisions. In response to this request, some medical schools have now integrated basic questions of cost with the standard considerations of diagnosis and treatment in their curricula.
This emphasis on cost containment has been stressed further by professional organizations such as the American Medical Association and the American College of Physicians as critical to making proper treatment decisions. Physicians are now being urged to become cost conscious by programs such as those designed to assess medical knowledge in preparation for the fulfillment of licensing and certification requirements. These programs evaluate physician decisions requesting tests and procedures in the diagnosis and management of given clinical conditions on the basis of cost to the patient, as well as such traditional factors as risk.
Physicians are thus being asked to include a whole new world of information on top of an already exponentially expanding body of conventional medical knowledge. Without new tools to provide assistance it is unrealistic to expect the majority of practicing physicians to contribute to effective cost reduction in the delivery of health services. Some hospitals have made attempts in this direction by instituting partially or fully computerized systems for presenting the results of diagnostic tests. While the available systems have helped physicians provide patients with the best available medical care, the information they present has not been organized with any conscious effort to save the physician's time and reduce costs. Accordingly, these systems do not enable the physician to assimilate significant information in a minimum amount of time so that information can be utilized optimally in patient care and management.
The greatest volume of information generated from diagnostic tests and procedures confronting the physician comes from those tests and procedures most often performed on hospitalized patients. These are most likely to be chemical and microbiological laboratory analyses of blood and other body fluids, x-rays, and electrocardiograms. All other diagnostic procedures, such as ultrasound examinations and isotopic scans of body organs, tend to be performed much less frequently. Of all of these diagnostic tests and procedures, the data generated by laboratory tests on blood is the most profuse and requires the most time for the physician to interpret and apply in making patient management decisions. For example, about one million of the 1.1 million diagnostic tests and procedures performed in one medium sized hospital, Kent County Hospital, Warwick, R.I., during one year were laboratory analyses of patients' blood. The data from these blood tests is quite diverse in nature and is quickly accumulated in massive amounts in patient records, especially if the hospital stay is a long one or the patient's clinical condition requires close monitoring of his blood chemistry. Unless this profusion of information is organized and presented in a format so that information regarding patient management is readily available, valuable physician time will be wasted in sifting through the mass of data to find the most significant test results.
In a large number of hospitals today, laboratory blood test results are entered manually by laboratory personnel on slips of paper approximately 7 inches by 3 inches in size including information regarding several sometimes unrelated tests which are then sent to the hospital floor and pasted in the patient's record by floor personnel. Each time a test is repeated, another slip reporting the results must be added to the petient's record. The physician who must utilize these blood test results to make a diagnosis, prescribe treatment and otherwise provide patient care is confronted with a confusing array of clinically unrelated data which can require considerable time to organize and assimilate before it can be used in any meaningful way. In the case of a patient whose clinical condition requires a long hospital stay or frequent laboratory blood analyses, the numbers of slips of paper containing test results can increase at a phenomenal rate. As the number of tests performed and, hence, the number of slips of paper increases, it becomes extremely difficult if not impossible for the physician to follow clearly the results of important tests and to determine the correctness of a diagnosis or the effectiveness of a prescribed course of treatment and therapy. In hospitals where such a system of presenting laboratory test data is in effect medical students or nurses are often required to make charts organizing the data so that the physician can make some sense out of it and devote more time to the patient. The time and cost consuming aspects of such a system are clear. It is neither cost effective nor beneficial to the quality of patient care for physicians to spend their time performing manual information processing tasks, especially when computer assisted methods of reporting diagnostic information are available.
However, computer assisted methods of reporting diagnostic information do not necessarily result in time savings to the physicians or other end users of the information. U.S. Pat. No. 4,053,951 discloses a system for recording and reproducing medical data which generates an individual patient report printout each time the data is recorded, which could be several times a day. The resulting multiplicity of individual slips are then compiled in the patient's chart in much the same way as the manual laboratory slips described above. While this system represents an improvement over previously used noncomputer assisted systems, the data is cumbersome to use and requires more time for evaluation than is desirable with an automated system.
While some of the automated data display systems presently in use have attempted to organize at least portions of the patient test data reports in some semblance of a relationship to recognized clinical conditions, none of the existing automated systems has fully integrated the relationship between diagnostic tests and the organ system related clinical conditions in which their use is indicated. An additional drawback presented by prior art systems producing hard copy reports of individual patient test data is the failure of such systems to present the test data in a truly cumulative form which enables the clinician to review at a glance a chronological listing of all the results of a particular test. Some hard copy reports display the data on which tests are performed across the top of the page and list the individual tests down the left margin, thus limiting the number of test results which can be chronologically displayed. The systems which use this format generally put four or five days worth of tests on each page of the patient test data report, which requires the end user to review many sheets of the patient report to follow the results of significant tests over the course of hospital stay which is more than four or five days in duration. Those systems which display test data across and the dates down the left margin of the patient test data report approximate more closely a truly cumulative report. However, some of these systems often print test data covering only a specified period of time on each page of the patient report. Therefore, all such reports must be saved since the information they contain will not appear in future reports.
An additional drawback of the automated systems for presenting patient test data presently in existence concerns the reference data and the way in which these systems indicate whether a test is within normal limits. Since the levels of most chemical substances in the blood depend upon the age and sex of the individual whose blood is analyzed, a truly meaningful patient test data report includes a reference range for each test which is adjusted to the age and sex of the patient. Some of the prior art systems do utilize reference ranges for which some adjustment has been made to take into account the age and sex of the patient. When this has been done, however, the pool of individuals from which the data has been drawn has not been as large as desirable to yield the best reference data.
If a test is outside the values determined to constitute the normal range, prior art systems have usually indicated this fact by printing an H or a + (for a value that is higher than the normal range) or an L or a - (for a value that is below the normal range). The end user of the patient test data report must then determine the significance of a test result outside the normal range. In the case of most commonly used diagnostic tests, the physician performs this task mentally in a minute or so based on his expertise. In the case of a diagnostic test or procedure which is used infrequently or when a consulting physician with a different area of expertise is called in, the indication of a test result outside normal ranges, while quite helpful, may necessitate the expenditure of considerable time to ascertain the significance of the suspect test result so that the information can be used correctly and effectively in the management of the patient's condition. Although such information has been provided as part of the raw data received from professional laboratory reports, no prior integrated hospital reporting system has been designed to incorporate such information. One known hospital system has utilized explanatory footnotes to describe, to a limited extent, abnormal cellular morphology, but this information was not generated as a result of comparing out-of-range test values with an established normal reference range.
In another partially automated system, employed at The Rhode Island Hospital, Providence, R.I., tests are grouped in one data package which relate to renal function and acid-base balance and in another some of the commonly used tests relating to liver function, both of which are clinically relevant data packages. However, the third and fourth data packages in this system do not share the same clinical orientation. the third combines indicia of liver function with those of parathyroid function and fat metabolism, while the fourth mixes therapeutic drug levels with a pancreatic function test and a metabolic test. Miscellaneous blood and urine chemistry tests are then listed randomly in a way that has no clinical orientation whatever. Normal ranges are presented with only some of the tests, the remainder being listed on a page separate from the patient test data report. In this system, however, all other diagnostic laboratory tests, including all blood tests commonly referred to as hematology tests, are reported manually on slips of paper as described above.
Still another system, which is fully automated and has been in use at Roger Williams Hospital in Providence, R.I. since 1971, presents one blood chemistry data package containing twelve separate tests in the order these tests are performed by the automatic blood analyzer operated by the hospital's laboratory. These tests are not performed in any organ system specific, clinically related order; therefore, the presentation of this data in the patient test data report does not facilitate the physician's performance of diagnostic and clinical patient management functions. Another data package produced by this system includes liver, kidney and metabolic tests arranged in a way which requires the unnecessary expenditure of valuable professional time to assimilate and interpret. Still another data package is labeled "Enzymes" and is somewhat clinically oriented in that it contains the remainder of the liver function tests not performed by the automatic analyzer. Such a data package, however, presents only a partial picture of the clinical condition to the end user of the data. This system includes an additional data package entitled "Elect:" (Electrolytes) which contains tests relating to acid-base balance, but only a single test of kidney function. This, too, presents data in a form which does not give the physician a complete picture. Other critical kidney function data which would enable the physician to evaluate acid-base balance/renal function interrelationships is buried with liver function data. Results of all other laboratory blood tests are randomly listed so that there is no logical clinical relationship between them. For example, an activated partial thromboplastin time (APPT) test, which relates to blood coagulation, is followed by a serum amylase level, which is indicative of pancreatic function. This system has also incorporated microbiological tests in the hard copy of the patient test data report. However, the format in which this information is presented is analogous to a compilation of manually printed slips since the microbiological data generated each time a body site is cultured occupies a space on the page about the size of one of the traditional manual laboratory slips. In addition, the data is not cumulative, thus requiring the physician to flip through many pages to determine, for example, if a prescribed course of antibiotic therapy is effective. A further problem encountered by the end user of the above described system is posed by the generally noncumulative nature of the entire data presentation. It accumulates all the data from certain tests for only a limited time period before reporting it in the hard copy of the patient test data report. Since this data will not appear in future reports, the page containing it must be retained to maintain a complete record. The test data report of a patient who spent four weeks in Roger Williams Hospital was over forty pages in length, and thus required a substantial amount of time for the physician to organize, assimilate, interpret and apply the information in the format generated by this system.
A third fully computerized system currently in use at the 500 bed Medical Center Hospital of Vermont, Burlington, Vt., presents in its patient test data report two data packages, one essentially complete and one missing an important element, which bear some clinical relationship to each other. The remainder of the test data is listed below these data packages. Unlike other systems which have listed test data vertically down the page, these are listed in somewhat of a related way. For example, the serum creatinine and BUN results, both important indicators of renal function, are set forth together. However, as a whole, the system is not designed to enable the end user of the information to focus on organ system related conditions in the most efficient way. Moreover, since the data in this system is cumulative for only seven days, the potential exists for a massive accumulation of data during a long hospital stay. This fact, coupled with the absence of a well-defined organ system relationship of the data, does not facilitate patient management for the clinician.
The patient test data report of still another fully computerized system recently instituted at Holyoke Hospital, Holyoke, Mass., is an improvement on the system just described in that all of the diagnostic tests are arranged in horizontal data packages so that the report is somewhat easier to follow. Two of the data packages in this system are essentially complete in that the data they present is sufficient to enable the end user to monitor a particular organ system related condition. These are data package labeled "Electrolytes -BUN- Creatinine", which contains most of the tests related to acid-base balance and renal function, and the data package labeled "Arterial Blood Gases", which includes the major information relative to changes in respiratory function. The remaining data packages provide, at best, only a partial picture of important organ system related clinical conditions. For example, the data package entitled "Enzymes" includes some of the diagnostic tests needed to diagnose, treat and follow liver dysfunction. However, to obtain a complete picture of liver function, it is necessary for the clinician to refer to a second data package which contains most of the rest of the clinically relevant information.
Only one prior art system, the patient test data reporting system offered by Burroughs Hospital Information System, is known which includes diagnostic data from other than laboratory tests in its patient test data. This system includes a concise statement of data generated from diagnostic radiology procedures in addition to the standard hematology and urinalysis data. However, the remainder of the patient test data report suffers from the same lack of orientation to clinically related conditions as the other prior art systems. For example, a blood chemistry data package generated by an automated laboratory analyzer is included under the heating of Hematology.
As can be appreciated from the above discussion, the known types of diagnostic test data presentation systems currently in effect range from those in which only some diagnostic data is reported by a computer assisted system to fully computerized presentations of information from laboratory analyses of blood and body fluids. Perhaps the most serious drawback presented by such computerized system lies in the difficulty encountered by the clinician or other end user in utilizing this information efficiently to manage patients. None of the known systems has attempted to include all known diagnostic tests and procedures within a single clinically oriented format. Moreover, none of the existing systems has organized all of the test data packages so that each data package includes tests which are diagnostic for certain organ system related medical conditions. All of the existing fully computerized systems present data from complete blood counts and differential blood counts together since most hospitals now have automated laboratory equipment which performs these laboratory tests. The patient test data report generated by these systems usually reflects the information in the order the tests are performed by this equipment. In addition, all existing fully automated systems put the standard information determined from a urinalysis in the same area of the patient test data report. Some of the existing systems have attempted to group together in data packages across the top of a page those diagnostic blood tests which are commonly ordered together. This has been attempted most often with tests which analyze the chemical composition of the blood. While grouping together those tests which are often ordered together may have some relationship to convenience, such an arrangement is not always the most clinically relevant one. No single computer assisted system has been developed which collects data from diagnostic laboratory tests and diagnostic procedures and reports it in a condensed, organized and clinically relevant form that is specifically designed to assist the clinical physician, primary end user of the data, in making a clinical diagnosis, prescribing a course of treatment or therapy consistant with the diagnosed clinical condition, and readily following the effects of the prescribed treatment or therapy on the clinical condition during the patient's hospital stay.